Single setting 3D MRI-US guided frozen section and focal cryoablation of the index lesion in low/intermediate risk prostate cancer

Objectives: To explore the reliability of frozen sections to diagnose prostate cancer (PCa) and to describe surgical steps of a 3D magnetic resonance imaging (MRI)– ultrasound (US)-guided prostate biopsy (PB) and focal cryoablation of the index lesion in a single setting procedure. Patients and Methods: Patients with suspicious PCa, based on prostatic specific antigen (PSA) value and on a PIRADS 4 or 5 single lesion, as well as the steadfastness of avoiding any kind of radical treatment, were considered for enrolment. IRB and written informed consent were obtained from the patients. The entire procedure was performed transperineally, in two consecutive surgical phases: 3D MRI–US-guided plus systematic template PB and real-time TRUS-guided focal cryoablation. Three cores were taken from the index lesion (one for frozen section and two for final pathology), three cores from the surrounding area and systematic sampling was performed for the rest of the gland. Focal cryoablation of the index lesion was performed once confirmation of PCa was obtained by means of frozen sections. Follow-up schedule included PSA test at 3-mo interval, MRI 3-mo and 1-yr postoperatively and prostate biopsy of the treated area at 1-yr. 31 Results: This report includes 14 patients with a minimum follow up time of 12 months. All patients were potent before treatment, complained no severe low urinary tract symptoms and denied consent to any radical treatment. PCa diagnosis was histologically confirmed in all patients by frozen sections. All other cores were negative. At final histology, there was a Gleason score upgrade in three patients, from 3+3 to 3+4. The postoperative course was uneventful and all patients were discharged on the first postoperative day. Mean PSA value decreased from 6.37 (baseline) to 0.83 ng/mL at 3-mo evaluation. Three-mo postoperative MRI images showed complete ablation of the index lesion in all patients. Urinary continence and erectile function were preserved in all patients, without clinically meaningful changes at EPIC questionnaire. At one-yr follow-up, eleven patients showed no signs of persistent or recurrent disease at MRI imaging and treated area biopsies; three patients had a suspicious area at MRI and they needed treatment for confirmed disease at biopsy. Conclusion: Single setting 3D MRI–US-guided frozen section and focal cryoablation of the index lesion could represent a step forward towards a “patient-tailored” minimally invasive approach to diagnosis and cure of low and intermediate risk PCa.